Clinical Trials /

CyberKnife Radiosurgery for Locally Recurrent Prostate CA

NCT00851916

Description:

The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment. This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CyberKnife Radiosurgery for Locally Recurrent Prostate CA
  • Official Title: VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY

Clinical Trial IDs

  • ORG STUDY ID: CK Recurrent Prostate SD
  • NCT ID: NCT00851916

Conditions

  • Recurrent Prostate Cancer

Purpose

The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment. This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.

Trial Arms

NameTypeDescriptionInterventions
CyberKnife RadiosurgeryOtherSingle arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 -
                 T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate
                 radiotherapy.
    
              -  Karnofsky performance status >80.
    
              -  Greater than 5 year life expectancy
    
              -  Greater than 2 years since the original course of radiotherapy.
    
              -  Absence of distant metastases by radiologic or pathologic assessment.
    
              -  Absence of lymph node involvement by radiologic or pathologic assessment.
    
              -  Patients must sign a study-specific informed consent form prior to study entry.
    
            Exclusion Criteria:
    
              -  Stage T4 disease (AJCC 6th Edition, see Appendix II).
    
              -  Less than 2 years since the original course of radiotherapy.
    
              -  Lymph node involvement (N1).
    
              -  Evidence of distant metastases (M1).
    
              -  Radical surgery for carcinoma of the prostate
    
              -  Previous or concurrent cancers other than basal, in situ, or squamous cell skin
                 cancers unless disease-free for ≥ 5 years.
    
              -  Major medical or psychiatric illness, which in the investigator's opinion, would
                 prevent completion of treatment and would interfere with follow-up.
    
              -  History of inflammatory bowel disease
    
              -  Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Establish pattern of PSA decline
    Time Frame:Post CyberKnife Radiosurgery - 5 year f/up
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
    Time Frame:Post CyberKnife Radiosurgery/5 yr. f/up
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:CyberKnife Centers of San Diego

    Last Updated

    July 18, 2017